Methods and Apparatus to Shape Flexible Entry Guides for Minimally Invasive Surgery

ABSTRACT

An apparatus for performing surgical procedures is disclosed including a flexible entry guide tube and a first steering device. The guide tube has one or more lumens extending along its length from a proximal end to substantially at or near a distal end. At least one of the one or more lumens is an instrument lumen with open ends to receive a flexible shaft of a surgical tool. The first steering device is insertable into the instrument lumen to shape the guide tube as it is inserted through an opening in a body and along a path towards a surgical site. The apparatus may further include a flexible locking device to couple to the flexible entry guide tube and selectively rigidize the guide tube to hold its shape. The guide tube may be steered by remote control with one or more actuators.

CROSS REFERENCE TO RELATED APPLICATIONS

This non-provisional United States (U.S.) patent application is adivisional application of and claims the benefit of U.S. patentapplication Ser. No. 12/165,633 entitled “METHODS AND APPARATUS TO SHAPEFLEXIBLE ENTRY GUIDES FOR MINIMALLY INVASIVE SURGERY,” filed on Jun. 30,2008, which in turn claims the benefit of and is a continuation-in-partof U.S. patent application Ser. No. 11/762,165, entitled MINIMALLYINVASIVE SURGICAL SYSTEM, filed on Jun. 13, 2007, and also claims thebenefit of and is a continuation-in-part of U.S. patent application Ser.No. 11/491,384, entitled ROBOTIC SURGERY SYSTEM INCLUDING POSITIONSENSORS USING FIBER BRAGG GRATINGS, filed on Jul. 20, 2006, all of whichare incorporated herein by reference.

FIELD

The embodiments of the invention relate generally to guide systems forrobotic tools or instruments.

BACKGROUND

Minimally invasive surgical (MIS) procedures have become more commonusing robotic (e.g., telerobotic) surgical systems. Even still, a numberof minimally invasive surgical procedures are performed using aplurality of surgical tools which are inserted through a plurality ofopenings in a patient's body. If openings into a patient's body areformed by cutting, they must be closed and allowed to heal. If theopenings through which the surgical procedures are performed are reducedto a single opening, the time for recovery and risks of infection for apatient may be reduced. Moreover if the size of the one or more openingsinto the body can be reduced, it may be easier to close after theminimally invasive surgical procedure.

Additionally, the human body has a number of natural orifices throughwhich surgical tools may be inserted. For example, the nostrils in thenose or the throat in the mouth of a patient may be used to perform someminimally invasive surgical procedures. The use of a natural orifice forsome minimally invasive surgical procedures may permit a quickerrecovery with little to no visible scarring.

Moreover, some surgical procedures must traverse long distances and/oropen spaces within a human body to reach the surgical site from anopening. While endoscopes are often used to access such surgical sites,they are often limited in their ability to reach sites in an open spacethat lie substantially away from their direction of insertion. And whilemany endoscopes are capable of retroflexing one hundred eighty degrees,the short length of their articulated tips generally limits theirmaximum radius of curvature when so bent, which thus limits their reachwithin the abdomen. An exemplary surgical procedure is a trans-gastriccholecystectomy. For this surgical procedure, an endoscope may beinserted via the esophagus, through the wall of the stomach, and intothe peritoneum far enough to reach into the lower abdomen and then,because of the limitations of its articulation, must follow the edges ofthe cavity around and back up to the gall bladder. Thus, an endoscope,capable of being articulated over long portions of its length to reach asurgical site that does not lie in the direction of initial insertion,is desired.

BRIEF SUMMARY

The embodiments of the invention are summarized by the claims thatfollow below.

BRIEF DESCRIPTIONS OF THE DRAWINGS

FIG. 1A is a block diagram of a robotic medical system including anentry guide system for one or more robotic surgical tools.

FIG. 1B is a perspective view of a patient side cart including a roboticsurgical arm with a platform to support and move a proximal end of anentry guide and the robotic surgical tools that may be inserted therein.

FIG. 1C is a perspective view of a robotic surgical master controlconsole to control the robotic surgical arm and the insertion of theentry guide into a patient.

FIG. 1D is a magnified perspective view of a portion of a roboticpatient-side system with a flexible guide tube for robotic surgicaltools to perform minimally invasive surgery through a single port, and1E is a magnified perspective view of an actuator assembly of a roboticpatient-side system.

FIG. 2 is a perspective view of a distal end portion of the flexibleguide tube with a plurality of robotic surgical tools extending outthere-from.

FIG. 3A is a perspective view of a robotic surgical tool with a flexibleshaft for use with the flexible guide tube of the robotic surgicalsystem.

FIG. 3B is a cutaway perspective view of a proximal end of the roboticsurgical tool of FIG. 3A is illustrated.

FIG. 3C is a perspective view of a portion of the flexible shaft of therobotic surgical tool.

FIG. 4A is a perspective view of an entry guide having a proximal endcoupled to the platform.

FIG. 4B is a perspective view of a portion of the flexible entry guideof FIG. 4A.

FIG. 4C is an exploded view of the various vertebrae that form flexibleentry guide of FIG. 4A

FIGS. 4D, 4E, and 4F are top views of how the entry guide may couple tothe platform.

FIG. 4G is a perspective view of another entry guide having a proximalend coupled to the platform.

FIGS. 5A, 5B, and 5C are schematic drawings of an entry guide systemincluding a pair of robotic surgical tools.

FIGS. 5D and 5E are perspective views of the distal end of the entryguide.

FIGS. 5F, 5G, 5H are schematic views to illustrate how robotic surgicaltools may be used to steer the distal end of the entry guide.

FIGS. 5I, 5J, and 5K are schematic views of an entry guide system toillustrate how robotic surgical tools may be used in series withinlumens to steer the distal end of the entry guide.

FIGS. 6A, 6B, and 6C illustrate cut-away views of a roboticallycontrolled flexible locking sleeve.

FIGS. 7A, 7B, and 7C are schematic views of an entry guide systemincluding a plurality of steering tools that extend out of a lumen toshape and steer the entry guide to the surgical site.

FIGS. 8A, 8B, 8C, 8D, 8E, and 8F are schematic views of an entry guidesystem including a plurality of pre-curved rods that extend out of thelumens at the distal end to scout out and select the path of the entryguide to shape and steer the entry guide to the surgical site.

FIGS. 9A, 9B, 9C, 9D, 9E, and 9F are schematic views of an entry guidesystem to illustrate how robotic surgical tools may be used in series tosteer the distal end of the entry guide.

FIG. 10 is a cutaway side view of the distal end of the entry guide toillustrate an integrated camera tool aligned with a closed end of alumen.

DETAILED DESCRIPTION

In the following detailed description of the embodiments of theinvention, numerous specific details are set forth in order to provide athorough understanding of the present invention. However, theembodiments of the invention may be practiced without these specificdetails. In other instances well known methods, procedures, components,and circuits have not been described in detail so as not tounnecessarily obscure aspects of the embodiments of the invention.

Introduction

Methods and apparatus for influencing the behavior (e.g. shape,stiffness, range of motion, bend radius, etc) of a flexible entry guideare disclosed. A flexible entry guide is a flexible tube-shaped devicewith one or more interior lumens to guide shafts of one or moreendoscopic robotic surgical instruments to a surgical site and/orsupport such instruments and react to surgical forces once at thesurgical site. A typical entry guide may have two to four lumens sizedto accommodate instruments or tools which may be inserted down a lumenfor any purpose. For example, an instruments or tools which may beinserted down a lumen may be endoscopic cameras, graspers, scissors,cautery tools, etc. A tube to provide suction or irrigation is a simpleinstrument that may be inserted down a lumen. An inflatable device toretract or displace tissue is likewise an instrument that may beinserted down a lumen.

It may be advantageous to change robotic surgical tools during asurgical procedure for several reasons. A different tool may be neededat different steps within a procedure. A tool may be withdrawn from asurgical site to remove a tissue sample. A tool may be withdrawn forcleaning. A tool may be withdrawn for replacement because of afunctional failure.

Numerous control cables may be used actuate lengthy entry guides and canutilize a significant portion of the cross-sectional area of the entryguide. The control cables may be used to actuate the entry guide byproviding either steering or locking functions, or both. The instrumentlumens take up some cross-sectional area of the entry guide as well. Iffewer control cables are used to actuate the flexible entry guide, crosssectional area may be reduced or additional and/or larger lumens may beprovided within the entry guide. The force that a cable-driven surgicalinstrument can exert and the stiffness provided by the instrument inresponse to imposed external forces, are both roughly proportional tothe cube of the diameter of the body of the surgical instrument. Thus,providing a larger portion of the cross section of the flexible entryguide for instrument lumens allows for a substantial increase in theperformance of those instruments.

Instead of using control cables alone to actuate the entry guide, one ormore devices may be inserted into the one or more lumens to influencethe behavior of the entry guide. The methods and apparatus disclosedherein may enhance the performance (e.g. stiffness, range of motion,minimum achievable bend radius, etc) of the entry guide, reduce itscomplexity, and/or diameter by transferring some or all of its actuationmeans to devices that may be temporarily inserted into the lumens.

Given the competing constraints on the cross-sectional area of the entryguide, the embodiments of the invention make use of the space requiredby the instrument lumens to accomplish some or all of the entry guideactuation functions using fewer control cables. Instead, rigidstiffening devices may be inserted into the instrument lumens to modifythe flexibility of an entry guide such that a larger workspace ofsurgical sites may be reached with little interaction to the surroundingtissue. Alternatively, steering devices may be inserted into theinstrument lumens to steer or assist in steering all or portions of theentry guide.

Robotic Surgical System

Referring now to FIG. 1A, a block diagram of a robotic surgery system100 is illustrated to perform minimally invasive robotic surgicalprocedures using a master control console 150 and a patient side cart152. Aspects of system 100 include telerobotic and autonomouslyoperating features. Robotic surgery may be used to perform a widevariety of surgical procedures, including but not limited to opensurgery, neurosurgical procedures (e.g., stereotaxy), endoscopicprocedures (e.g., laparoscopy, arthroscopy, thoracoscopy), and the like.

A user or operator O (generally a surgeon) performs a minimally invasivesurgical procedure on patient P by manipulating control input devices160 at a master control console 150. A computer 151 of the console 150directs movement of robotically controlled endoscopic surgicalinstruments 101A-101E via control lines 159, effecting movement of theinstruments using the robotic patient-side system 152 (also referred toas a patient-side cart).

The patient side cart 152 includes a robotic arm 158 that can bemanipulated by a surgeon O at the master control console 150. Therobotic arm 158 is coupled to a platform 112 to support an entry guide108 and a plurality of robotic surgical tools 101A-101E inserted intothe entry guide 108. As the platform 112 is a moveable platform thatmoves with the robotic arm 158, it may raise and lower the entry guide108 as it is inserted through an opening in the patient P on the tableT. The robotic arm 158 and the platform 112 may also twist, turn, andangle the proximal end of the entry guide 108 as it is inserted. Theplatform 112 may also support actuators (See FIG. 4A) coupled to controlcables to robotically steer the distal end and portions of the body ofthe entry guide 108 within the patient to a surgical site.

The entry guide 108 may include a camera as part of its distal end.Alternatively, a stereo or three-dimensional surgical image capturedevice may be inserted into an instrument lumen of the entry guide 108,such as a stereo endoscope (which may be any of a variety of structuressuch as a stereo laparoscope, arthroscope, hysteroscope, or the like),or, optionally, some other imaging modality (such as ultrasound,fluoroscopy, magnetic resonance imaging, or the like). For example, therobotic instrument 101B may be an image capture device and the roboticinstruments 101A and 101C-101E may be used to manipulate tissue.

Robotic instruments are generally referred to herein by the referencenumber 101. Robotic instruments 101 may be any instrument or tool thatis inserted into the entry guide 108 that can be manipulated by one ormore actuators under remote control of the master control console 150.Robotic instruments include, but are not limited to, surgical tools,medical tools, biomedical tools, and diagnostic instruments (ultrasound,computer tomography (CT) scanner, magnetic resonance imager (MRI)).

Generally, the robotic patient-side system 152 may include a positioningportion and a driven portion. The positioning portion of the roboticpatient-side system 152 remains in a fixed configuration during surgerywhile manipulating tissue. The driven portion of the roboticpatient-side system 152 is actively articulated under the direction ofthe operator O generating control signals at the surgeon's console 150during surgery. The driven portion of the robotic patient-side system152 may include, but is not limited or restricted to the roboticsurgical arm 158, the entry guide 108, and the robotic instruments ortools 101.

As an exemplary embodiment, the positioning portion of the roboticpatient-side system 152 that is in a fixed configuration during surgerymay include, but is not limited or restricted to a set-up arm 156. Theset-up arm 156 may include a plurality of links and a plurality ofjoints 157. The set-up arm mounts via a first set-up-joint 157 to thepatient side system 152.

An assistant A may assist in pre-positioning of the robotic patient-sidesystem 152 relative to patient P as well as swapping tools orinstruments 101 for alternative tools or instruments, and the like,while viewing the internal surgical site via an external display 154.The external display 154 or another external display 154 may bepositioned or located elsewhere so that images of the surgical site maybe displayed to students or other interested persons during a surgery.Images with additional information may be overlaid onto the images ofthe surgical site by the robotic surgical system for display on theexternal display 154.

Referring now to FIG. 1B, a perspective view of the robotic patient-sidesystem 152 is illustrated. The robotic patient-side system 152 comprisesa cart column 170 supported by a base 172. The robotic surgical arm 158is attached to a set-up arm 156 that pivotally couples to the column 157through a setup joint 157. The set up joint 157 is coupled to a carriagehousing 190 so that the robotic surgical arm 158 may be raised andlowered and setup into position prior to surgery near the patient.

The robotic surgical arm 158 is a part of the positioning portion ofrobotic patient-side system 152. The robotic surgical arm 158 is used tocontrol the actuation of the robotic instruments 101A-101C and the entryguide 108. The robotic surgical arm 158 includes an actuating end 116with a moveable platform 112 to which the plurality of roboticinstruments 101A-101C and the entry guide 108 may couple.

Referring now to FIG. 1C, a perspective view of the robotic surgicalmaster control console 150 is illustrated. The master control console150 of the robotic surgical system 100 may include the computer 151, abinocular or stereo viewer 164, an arm support 194; a pair of controlinput wrists, control input arms, and motion sensitive handles 160 in aworkspace 196; foot pedals 198 (including foot pedals 318A-318B), and aviewing sensor 193. The master control console 150 may further include amicrophone 195 and a speech recognitions system 197 coupled together andto the computer 151 for receiving audible commands and instructions.

The stereo viewer 164 has two displays where stereo three-dimensionalimages of the surgical site may be viewed to perform minimally invasivesurgery. When using the master control console, the operator O typicallysits in a chair, moves his or her head into alignment with the stereoviewer 164 to view the three-dimensional annotated images of thesurgical site. To ensure that the operator is viewing the surgical sitewhen controlling the robotic instruments 101, the master control console150 may include the viewing sensor 193 disposed adjacent the binoculardisplay 164. When the system operator aligns his or her eyes with thebinocular eye pieces of the display 164 to view a stereoscopic image ofthe surgical worksite, the operator's head sets off the viewing sensor193 to enable the control of the robotic instruments 101. When theoperator's head is removed the area of the display 164, the viewingsensor 193 can disable or stop generating new control signals inresponse to movements of the motion sensitive handles in order to holdthe state of the robotic instruments. The processing required for tooltracking and image guided surgery may be entirely performed usingcomputer 151 given a sufficiently capable computing platform.

The arm support 194 can be used to rest the elbows or forearms of theoperator O (typically a surgeon) while gripping motion sensitive handlesof the control input wrists, one in each hand, in the workspace 196 togenerate control signals. The motion sensitive handles are positioned inthe workspace 196 disposed beyond the arm support 194 and below theviewer 164. This allows the motion sensitive handles 160 to be movedeasily in the control space 196 in both position and orientation togenerate control signals. Additionally, the operator O can use his feetto control the foot-pedals 198 to change the configuration of thesurgical system and generate additional control signals to control therobotic instruments 101 as well as the endoscopic camera.

The computer 151 may include one or more microprocessors 182 to executeinstructions and a storage device 184 to store software with executableinstructions that may be used to generate control signals to control therobotic surgical system 100. The computer 151 with its microprocessors182 interprets movements and actuation of the motion sensitive handles(and other inputs from the operator O or other personnel) to generatecontrol signals to control the robotic surgical instruments 101 in thesurgical worksite. The computer 151 and the stereo viewer 164 map thesurgical site into the controller workspace 196 so it feels and appearsto the operator that the motion sensitive handles 160 are working overthe surgical site.

Referring now to FIG. 1D, a portion of the patient side cart 152 isillustrated with an actuating end 116 of a robotic surgical arm ormanipulating arm 158. Other portions of the patient side cart 152 areillustrated in FIG. 1B to support the robotic surgical arm 158, theplatform 112, the entry guide 108, and the tools or instruments 101 overa patient P.

The general function of the actuating end 116 of the robotic ormanipulating arm 158 and the robotic surgical tools 101A-101C coupledthereto are described in more detail in U.S. patent application Ser. No.11/762,165 entitled MINIMALLY INVASIVE SURGICAL SYSTEM filed by Larkinet al. on Jun. 13, 2007, which is incorporated herein by reference.

A single guide tube 108 supported by the platform 112 of the robotic arm158 is used to insert the tools 101A-101C through an opening of thepatient P, such as the patient's mouth for example. The guide tube 108is coupled to the platform 112 which is in turn moveably coupled to therobotic arm 158. With one or more actuator mechanisms, the robotic armcan adjust the pitch, yaw, roll, and insertion along an insertion axisof the guide tube 108. The guide tube 108 may be maintained in a fixedposition or rotated (e.g., pitch, yaw, and/or roll) around a remotecenter point 120 near the opening into the patient if permitted by thecircumstances, including the tissue in the body where the tools may belocated.

The robotic surgical tools 101A-101C may be inserted into the entryguide in varying degrees. For example, the robotic surgical tool 101B isillustrated as being more fully inserted into the guide tube 108 incomparison with the other robotic surgical tools 101A and 101C. Therobotic surgical tools 101A and 101C are illustrated as being partiallyinserted into the guide tube 108 in FIG. 1D. The robotic surgical tools101A-101B may be different types of robotic surgical tools.

Referring now to back to FIG. 1B, a proximal end of the robotic surgicaltools 101A-101C are shown inserted into the guide tube 108 and coupledto a tool actuator assembly 140. Each tool 101A-101C may include aflexible body tube 106 inserted into the guide tube 108. The toolactuator assembly 140 is mounted to a linear actuator 110 (e.g., aservo-controlled lead screw and nut, or a ball screw and nut assembly)that independently controls each tool's further insertion within guidetube 108 along with its body tube's 106. The guide tube 108 may beremoveably mounted to the support platform 112 as further explainedherein with reference to FIGS. 4D-4F. Removable and replaceable guidetubes allow different guide tubes designed for use with differentprocedures to be used with the same telemanipulative system (e.g., guidetubes with different cross-sectional shapes or various numbers andshapes of working and auxiliary channels).

The actuator assembly 140 mates with and actuates components of therobotic surgical tools 101A-101C. The actuator assembly 140 includes aplurality of rotatable actuators 126 coupled to actuator disks 122. Eachactuator disk 122 includes holes to interface to pins of rotatableinterface disks of the robotic surgical tools. Each actuator disk 122 isrotated in response to control inputs from the master control console150 to remotely control the robotic surgical tool.

The actuator assembly 140 may include one or more actuators 111 toactuate the entry guide 108. In one embodiment of the invention, theactuators may be the one or more servo-motors. For example, one or moreactuators 111 may be used to actuate control cables to rigidize theentry guide 108 by actuating a locking tool inserted into or a part ofthe entry guide. In another embodiment of the invention, one or moreactuators 111 may be used to actuate control cables to steer the distalend and other points along the length of the entry guide into thepatient's body.

Referring now to FIG. 2, a distal end of the robotic surgical tools101A-101C is shown extending out from the distal end of the guide tube108. The guide tube 108 includes a plurality of channels or lumens 218,202 through which the respective robotic surgical tools 101B, 101A-101Bmay be inserted and extend. The guide tube 108 may further include anauxiliary channel 260 through which other robotic surgical tools may beintroduced or withdrawn, such as irrigation, suction, or cleaningdevices for example. As illustrated in FIG. 2, the body tube or shaft1006 of each respective robotic surgical tools 101A-101C may extend outfrom the respective channels or lumens of the guide tube 108. With theguide tube 108 entering natural orifices of a body its diameter and thediameter of each respective robotic surgical tool 101A-101C is limited.

Each of the respective robotic surgical tools 101A, 101C include endeffectors 248A, 248B coupled to their respective body tubes or shafts1006 by one or more joints 244A-244B, 246A-246B, and a parallel tube245A-245B. In one instance, the body tubes or shafts 106 for the roboticsurgical tools 101A, 101C is approximately 7 millimeters (mm) indiameter. In another instance, the body tubes or shafts 106 for therobotic surgical tools 101A, 101C is approximately 5 mm in diameter.Note larger diameter instruments can generally apply larger forces totissue, but generally require a larger diameter entry guide, and thusthe selection of instrument diameter can be procedure-specific.

Robotic Instruments With Flexible Shafts

Referring now to FIG. 3A, a perspective view of a robotic surgical tool101 is illustrated. The robotic surgical tool 101 includes a housing 301with a mountable base 304, a transmission mechanism 303, a body tube orshaft 106, and an end effector 348 coupled together. The housing 301 andthe transmission mechanism 303 are coupled to the proximal end of thebody tube 106 while the end effector 348 is coupled to the distal end ofthe body tube 106.

The end effector 348 is a steerable head and may be steered by controlcables actuated by rotatable drivers 310. The shaft 106 may be formed ofa plurality of pivotal vertebrae. The shaft 106 may include one or moresteerable/lockable vertebrae 316A-316D actuated by additional controlcables. Articulation of the vertebrae 316A-316D may steer sections ofthe shaft 106 where located. Tensioning of control cables coupled to thevertebrae 316A-316D may also lock one or more vertebrae in anarticulated position to make one or more respective portions 306A-306Dof the shaft rigid.

FIG. 3C illustrates a plurality of pivotal vertebrae 372-376. Thevertebrae 374 is one of the steerable/lockable vertebrae 316 that may besteered by a plurality of control cables 382 on opposing sides thatextend from the proximal end of the shaft to the vertebrae 316. The endeffector 358 may couple to the last vertebrae near the distal end of theshaft 106. The pivotal vertebrae 372-376 for the shaft 106 are describedin further detail in U.S. Pat. No. 6,817,974 entitled SURGICAL TOOLHAVING POSITIVELY POSITIONABLE TENDON-ACTUATED MULTI-DISK WRIST JOINTfiled by Thomas G. Cooper et al. on Jun. 28, 2002, which is incorporatedherein by reference.

Referring back to FIG. 3A, the transmission mechanism 303 provides amechanical interface for the tool 101 and includes a plurality ofrotatable interface disks 310. One or more of the rotatable interfacedisks 310 are associated with a degree of freedom of the roboticsurgical tool 101. For example, a rotatable interface disk 310 may beassociated with instrument body roll degree of freedom illustrated bythe doubled-headed arrow 318. The rotatable interface disks 310 may bearranged for compactness. Each rotatable interface disk 310 may includea pair of spaced apart raised pins 312. The raised pins 312 of eachrotatable interface disk may be spaced eccentrically to provide properdisk orientation when mated with an associated actuator disk. In otherembodiments of the invention, the transmission mechanisms may bedirectly coupled to motors or other actuators, or may be coupled byother detachable coupling means known in the art.

The transmission mechanism 303 includes a plurality of mechanicalcomponents (e.g., gears, levers, gimbals, cables, springs, etc.) toconvert roll torques 320 received by the rotatable interface disks 310and transmit the torque to control cables to actuate end effectors, tosteer the end effector and portions of the shaft, and rigidize portionsof the shaft. The movement of the robotic surgical tool 101 may becontrolled, such as roll 318 in the body tube 106 or pitch 319 in theend effector 348, for example. One or more cables, cable loops (e.g.,380,382), hypodermic tubes, flexible push rods, and/or any combinationthereof within the shaft 106 may be used to transfer the torque receivedby the transmission mechanism 303 to the lockable/steerable vertebrae316 along the shaft 106, such as the vertebrae 374, to steer the endeffector 348 and portions of the shaft.

The housing 301 may include one or more electronic interface connectors314 to provide an electronic interface for the robotic surgical tool101. The one or more of the electronic interface connectors 314 may beused to interface to one or more cameras in the end effector 348. Theone or more of the electronic interface connectors 314 may be used topass information stored in a semiconductor memory integrated circuit tothe master control console regarding the tool and its end effectors.Such passed information may include instrument type identification,number of instrument uses, and the like. The control system may be usedto update the stored information (e.g., to record number of uses todetermine routine maintenance scheduling or to prevent using aninstrument after a prescribed number of times). Other connectors for,e.g., optical fiber lasers, optical fiber distal bend or force sensors,irrigation, suction, etc. may be part of the housing 301.

Referring now to FIG. 3B, exemplary drive mechanisms and cableconnections are illustrated at a proximal end of a tool 101 for steeringthe steerable/lockable vertebrae and end effector. The tool 101 may haveone actuator per control cable 380,382. Each actuator may be coordinatedby a control system to pitch and yaw the steerable vertebrae in theshaft with the control cables to follow various motion profiles.

For each control cable 380,382 the transmission mechanism may includeone or more pulleys 366 to direct the cable to a spool or capstan 352 topay in or out the cable. The proximal end of the drive cables 380,382are wrapped around the capstan 352 to control the movement of thesteerable/lockable vertebrae and end effector. The capstan 352 iscoupled to a first shaft 354 of a transmission 350. A second rotatableshaft 356 of the transmission 350 extends through the base 304 and iscoupled to the rotatable receiver 310. The one or more pulleys 366 arepivotally coupled to one end of a shaft 360 with the opposite end of theshaft 360 being coupled to the housing 301.

Each rotatable receiver 362 of the tool mates with a rotatable driver ofthe robotic surgical arm when mounted thereto. As the rotatablereceivers 362 are driven by a rotatable driver of the robotic surgicalarm, the transmission transfers the rotational motion to the capstan 352to take in or pay out the control or drive cables 380,382. A pluralityof rotatable receivers 362 may be simultaneous driven to move aplurality of drive cables 380,382 in the shaft 106 to obtain a mixtureof pitch and yaw movement in one or more steerable vertebrae.

The drive cables 380,382 may be controllably actuated by a variety ofalternative actuators and drive mechanisms, such as motor-drivenlinkages, hydraulic actuators, electromechanical actuators, linearmotors, magnetically coupled drives and the like.

Lockable Flexible Entry Guide

Referring now to FIG. 4A, a perspective view of an entry guide 108A isshown for one embodiment of the entry guide 108. The entry guide 108Ahas a proximal end 401 and a distal end 402. The entry guide 108A mayhave a cylindrically shaped cross-section which may be circular as shownor of a non-circular shape, such as a rectangular or oval shape.

The entry guide 108A may be formed of a plurality of pivotally coupledvertebrae 472-475. The vertebrae 472-475 are rigid segments that areassembled together to be flexible. Alternatively, the entry guide may beformed of a flexible material such as a high performance engineeringthermoplastic (e.g., polyoxymethylene, DELRIN by Dupont, or a lineararomatic polymer PolyEtherEtherKetone (PEEK)). In this case, the entryguide may be shaped (e.g. notched or corrugated) to provide one or moreregions of higher flexibility along its length by reducing the diameteror the thickness in one direction perpendicular to the major axis. Theentry guide 108A may be covered by a flexible sheath or sleeve 408 toprovide a smooth surface to avoid snagging tissue in the body cavity andkeep out fluids and tissue to ease cleaning.

The entry guide 108A includes one or more instrument lumens 405A-405Ewhich guide a respective one or more inserted surgical tools from theproximal end to the distal end of the entry guide. After the entry guideis inserted, the instrument lumens provide the routing for a flexibleshaft of a surgical tool to reach the surgical site. During a surgicalprocedure, instruments may be withdrawn via these lumens and replacedwith other instruments.

The instrument lumens may be hollow open ended cylindrical passageswithin the entry guide extending from the proximal end to the distalend. In some cases, the entry guide may have a lumen that is open at theproximal end of the entry guide but closed near the distal end. In thiscase, a fixed tool substantially aligned with an axis of the lumen atthe closed end may be included in the distal end of the entry guide 108A(see FIG. 5A). For example, an electronic tool, such as a CCD camera forcapturing video images and/or one or more light emitting diodes forlighting, may be provided in the distal end of the entry guide 108Abeyond the closed lumen opening.

The instrument lumens, such as instrument lumens 405A,405C,405D, may beof the same size and shape to receive commonly designed robotic surgicaltools with the similar cross-sectional dimensions but differentcapabilities. In one embodiment of the invention, the robotic surgicaltools have a circular cross section. Other instrument lumens, such aslumen 405B, may have a different shape (e.g., rectangular or triangularlike shape) along a portion of the entry guide (such as the distal end)so that the shaft of the tool inserted therein is keyed to the lumen sothat it rotates with that portion of the entry guide, such as formaintaining endoscopic camera orientation. Alternatively, a lockingdevice may be used to couple a portion of a shaft of a tool to the lumenwall of the entry guide, such as shown and described with reference toFIGS. 5D-5E. The locking device between the tool shaft and the lumenwall may also be referred to as a lumen attachment device or mechanismfor attaching a portion of the tool shaft to the lumen wall of the entryguide.

One or more locking devices may be positioned along the length of theshaft and/or lumen wall of a lumen to couple the shaft of a tool todiffering positions along the entry guide. For example, intermediateportions of the entry guide may be steered by a tool attached atintermediate portions of the lumen. A plurality of attachment mechanismsmay be positioned along a given lumen of the entry guide or along agiven instrument/tool. The plurality of attachment mechanisms may beselectively enabled and disabled to selectively couple differingportions of the tool shaft to differing portions of a lumen wall of theentry guide. The different positions of the attaching mechanisms mayallow for pushing and/or pulling on the instruments/tools to steer someintermediate or distal portion of the entry guide.

A torque applied at a proximal end of the shaft of a tool inserted intoand locked or keyed to lumen 405B may be able to rotate a portion of theentry guide 108A, such as the distal end. Alternatively, rotation of theshaft of a tool inserted into and locked or keyed to the lumen 405B ofthe entry guide 108A may be deterred. An endoscopic camera, for example,inserted into the lumen 405B and keyed thereto will maintain its pointof view with respect to the distal end of the entry guide 108A and othersurgical tools extending out from the end of the entry guide. With theshaft of a tool keyed to the lumen, external torques applied to theinstrument tip, resulting in rolling moments about the longitudinal axisof the instrument where it exits the lumen, may be transmitted to theentry guide, which may be locked to provide a torsionally stiff platformto react to the external torques.

Other lumens may be smaller in size, such as lumen 405E, to receive aspecial type of tool, such as a locking or stiffening tool and tominimize cross-section area being used. The lumens may be strategicallylocated in the cross-section to provide maximum functional effect. Forexample, the lumen 405E that may be used to rigidize the entry guide,may be located along a center axis of entry guide 108A. The lumens may,for example, be positioned on opposite sides (e.g., left and rightsides) so that the robotic surgical tools inserted therein may exertmaximum leverage when used to assist in steering the entry guide 108A.In one embodiment of the invention, the length of the entry guide 108Amay be approximately one meter to extend through a body cavity and thediameter may be approximately twenty millimeters to allow a plurality ofrobotic surgical tools with flexible shafts to be inserted therein.

The proximal end 401 of the entry guide 108A may be removeably coupledto the platform 112 by a fastening means 430. Embodiments of thefastening means 430 to couple the entry guide to the platform areillustrated in FIGS. 4D-4F. The platform 112 supports the entry guide108A and its housing 400 over the patient such that gravity may assistin the insertion of the entry guide 108A into the patient's body. Theplatform 112 may be moved to support the entry guide at differentangles. The platform 112 may be manually moved by use of the set-up arm156, set up joint 157 and the carriage housing 190 coupled to the column157 of the patient side cart 152. The platform 112 may be roboticallymoved by remote control by use of the robotic arm 158 that can bemanipulated by a surgeon O at the master control console 150.

The entry guide 108A may include one or more steering cables 482A-482Bthat may be used to steer at steering points 410A-410N along the lengthof the entry guide under computer control. The steering point 410N at ornear the distal end 402 is used to steer the distal end 402 of the entryguide 108A while steering points 410A-410M are used to steer the body ofthe entry guide 108A. The entry guide 108A or a locking tool may includeone or more locking cables 483 to rigidize the flexible entry guide 108Aalong its spine. The steering cables 482A-482B when pulled concurrentlymay be used to further rigidize the flexible entry guide 108A.

The steering cables 482A-482B may be taken in and paid out by one ormore actuators 111A-111B, respectively under remote control by acomputer, such as the computer 151 at the master console 150. One ormore locking cables 483 may be may be taken in and paid out by one ormore actuators 111C under remote control by a computer, such as thecomputer 151 at the master console 150.

The rotating motion of a rotating actuator may be simply coupled to acable by a spool or a capstan. For example, steering cables 482A-482Band locking cables 483 are each routed from the flexible shaft 401 intothe bell shaped housing 400 and couple to a spool or capstan 412 such asby wrapping around it. The capstan 412 is coupled to one end of arotatable shaft 411 extending through the housing 400 and coupled to anactuator. In this case, the actuators 111A-111C may be rotatableactuators.

Referring now to FIG. 4B, a perspective view of a series of vertebrae473-474 of the entry guide 108A at a body steering point 410 areillustrated. A plurality of steering cables 482A-482C are threadedthrough cable guide openings 421 in each of the vertebrae 473-474. Thesteering cables may be doubled in a cable loop such as steering cable482A for increased strength. The steering cable 482A is coupled to thesteering/lockable vertebrae 474 by a loop end so that it can actuate theentry guide at the body steering point 410. Other steering cables, suchas steering cable 482C, may be routed past the body steering point 410to actuate a more distal body steering point, such as point 410N.

The vertebrae 473-474 and adjacent vertebrae 473 can pivot against eachother at the meshing of a pair of lower gear segments 425 with a pair oftop gear segments 426. One or more alignment pins and alignment openingsmay also be used between adjacent vertebrae to retain the orientation ofadjacent vertebrae.

Referring now to FIG. 4C, an exploded view of vertebrae 472-475 of theentry guide 108A are illustrated without any steering or locking cables.Each of the vertebrae 472-475 include a plurality of openings 415A-415Ethat when flexibly assembled together form the lumens 405A-405E. Each ofthe vertebrae 472-475 includes a plurality of cable guide openings 421through which the control cables may be inserted. The edges of theopenings 415A-415E may be shaped to maximize the radii of curvature ofthe surfaces which contact the steering and locking cables when theentry guide is articulated to minimize friction and wear between thecables and the vertebrae.

The vertebrae 472 is at the proximal end of the entry guide and mayinclude a fastening means 430 to couple to the platform 112. Thefastening means 430 may be tabs as shown for a bayonet mount or a liparound outer edge with an engagement mechanism to couple the proximalend of the entry guide 108A to the platform 112. The vertebrae 472 has apair of bottom gear segments 425 to mate with a pair of upper gearsegments 426 of another vertebrae. The vertebrae 472 further has one ormore alignment openings 422 on opposing sides to mate with respectiveone or more alignment pins 423 to keep adjacent vertebrae in alignment.

The vertebrae 473-474 are used between the proximal end and the distalend of the entry guide 108A. Each of the vertebrae 473-474 includes apair of top gear segments 426 on a top surface and a pair of bottom gearsegments 425 on a bottom surface. The top and bottom gear segments maybe aligned with each other as shown by vertebrae 474 or they may beturned by ninety degrees, or another angular increment, as shown byvertebrae 473. Each of the vertebrae 473-474 may include one or moreopposing alignment pins 423 in a top side to mate with openings ofanother vertebrae and one or more opposing alignment openings 422 in abottom side to mate with pins of another vertebrae to prevent axialtranslation along the pivot line of one vertebra relative to the next.

The vertebrae 473-474 may be of the same thickness for uniformity ordiffering thickness. For example, the vertebrae 474 may have a greaterthickness in order to vary the bend characteristics of the entry guidealong its length.

An end vertebrae 475 is at the distal end of the entry guide 108A andmay have one or more robotic surgical tools extend from it into thesurgical site through openings 415A-415D, 415E′. However, the vertebrae475 may include one or more openings, such as opening 415E′ with a topopening and a closed bottom to form a closed distal end of a lumen sothat a tool, such as a camera may be integrated into the entry guide108A. FIG. 10 illustrates a camera 1002 integrated into the distal endof an entry guide behind a lumen 405B′ with a closed distal end. Thevertebrae 475 has a pair of upper gear segments 426 to mate with a pairof bottom gear segments 425 of vertebrae above it. The vertebrae 475further may have one or more alignment pins 423 on opposing sides tomate with one or more alignment openings 422 on opposing sides in theneighboring vertebrae.

The vertebrae of the entry guide 108A are formed of metal, such asstainless steel, in accordance with an aspect of the invention.Alternate embodiments of the entry guide 108 may be formed of othermaterials such as composite materials, e.g. carbon-epoxy composite, highstrength plastics, e.g. acetal, polycarbonate, PolyEtherEtherKetone(PEEK), or the like.

Referring now to FIG. 4G, a perspective view of an entry guide 108B, analternate embodiment of the entry guide 108, is shown. The entry guide108B may have similar elements and features of the entry guide 108A,such as the lumens 405A-405E. However instead of being formed ofmetallic vertebrae, the entry guide 108B is formed of a high performanceflexible plastic (e.g., polycarbonate, acetal, or a linear aromaticpolymer such as PolyEtherEtherKetone (PEEK)), high durometer natural orsynthetic rubber, or other flexible material. The entry guide 108B maybe periodically notched with a series of linear notches 409 near aplurality of steering points 410A-410N so that it may sufficiently flexto make turns as it is inserted into a body cavity. The linear notches409 are v-shaped grooves. The linear notches 409 may alternatively becorrugation. A flexible sheath or sleeve 408 (see FIG. 4A may hide fromview the linear notches or corrugation 409 as well as keep debris fromthe notches as the entry guide is inserted into a body cavity. Thecorrugation 409 may be circular corrugation or non-circular corrugationin one embodiment of the invention. The high performance flexiblematerial may be less expensive to manufacture and assemble into an entryguide 108B. An entry guide 108B formed of inexpensive materials may beused once and disposed of afterwards without having to undergo asterilization process. Devices disclosed herein may provide additionalstiffness to ease insertion of the flexible entry guide 108B.

FIGS. 4D-4F illustrate top views of different embodiments of how theentry guide 108 may be supported and mounted to the platform 112. FIGS.4D-4F illustrate platforms 112D-112F respectively supporting the entryguide 108 with different proximal vertebrae 472D-472F.

In FIG. 4D, the platform 112D is formed of two parts, a back portion112B that is coupled to the robotic arm 158 and a front portion 112Athat couples to the back portion 112B. A plurality of fasteners 439 maybe used to hold the front portion 112A and the back portion 112B coupledtogether. The front portion 112A may be detached from the back portion112B so that the entry guide 108 may be readily mounted to anddismounted from the platform 112D within the opening 435. The proximalvertebrae 472D may include may include a lip 433 around its upper outeredge to support the entry guide 108. The proximal vertebrae 472D mayinclude one or more engagement devices (e.g., tabs) 431 around itsperimeter that may be fastened to the platform 112D by fasteners 432.The platform 112D may include threaded openings below the tabs 431 toreceive a threaded bolt (fastener) 432.

In FIG. 4E, a bayonet type mounting may be used to couple the proximalend of the entry guide 108 to the platform 112E. The proximal vertebrae472E may include one or more tabs 431 around its perimeter that whenrotated may be fastened to the platform 112D by locking receptacles 433around the opening 435. The platform 112E may be formed of one piece ortwo pieces and coupled to the robotic arm 158. The distal end of theentry guide 108 may be inserted first into the opening 435.

In FIG. 4F, a lock nut 436 may be used to couple the proximal end of theentry guide 108 to the platform 112E. The proximal vertebrae 472F mayinclude a threaded exterior 437 around its perimeter that may beinserted up through opening 435 with the control cables, if any. One ormore lock nuts 436 include an internal threaded opening 438 that mayengage the threaded exterior 437 of the proximal vertebrae 472F to mountthe entry guide to the platform 112F. The platform 112F may be formed ofone piece or two pieces and coupled to the robotic arm 158. In analternate embodiment, the lock nut 436 may instead be a clamping devicethat can open to release and close to engage and clamp around thevertebrae 372F to mount the entry guide 108 to the platform 112F.

To reduce the diameter of the entry guide the number of cables used toshape the entry guide during insertion into a patient may be reduced innumber or eliminated entirely. Instead, the lumens may be used bydevices to shape or assist in shaping the entry guide as it is insertedthrough an opening or orifice of a body or patient to a surgical site.After the entry guide is locked in position, flexible steering devicesmay be removed from the instrument lumens. The one or more open lumensmay then be used to guide one or more robotic surgical tools through theopening in the body to the surgical site to perform the surgery. In oneembodiment of the invention, the instrument lumens may also be used tomake the entry guide rigid or stiff so as to lock its position withinthe body so that a surgery may be performed in a surgical site. Aftersurgery is completed, a lumen may also be used to assist in the releaseof the rigidity or stiffness in the entry guide so that it may beremoved from the patient through the opening from which is was inserted.

In an alternate embodiment of the invention, the entry guide itselfincludes a locking mechanism so that one or more cables may be used tomake the entry guide rigid or stiff.

Instrument Guidance of the Entry Guide Tube

In one embodiment of the invention, the robotic surgical tools orinstruments 101 themselves may be inserted into the lumens of the entryguide 108 and used to steer the entry guide around body tissueobstructions and towards a surgical site.

Referring now to FIGS. 5A-5C, a schematic view of a minimally invasivesurgical instrument assembly 500 is illustrated. The surgical instrumentassembly 500 illustrates that two or more surgical instruments that mayrun longitudinally through entry guide 504 in individual channels orlumens 506A, 506B, respectively from a proximal end to at or near adistal end thereof. The surgical instruments 502A, 502B may be, forexample, snap-fitted into non-rotating sockets within the lumens 506A,506B to maintain position within the entry guide 504. Other types ofretention, locking, or attachment means, such as inflatable bladders(e.g., inflatable balloon or inflatable cylinder) around the perimeterof a distal section of the instrument, or deployment of mechanicallyexpandable cams, collars or spring latches, may alternatively beemployed to secure the distal portion of the instrument at one or morespecific locations within the lumen of the entry guide. An inflatablebladder expands between the wall of the lumen and the outside surface ofthe surgical tool. The entry guide 504 may have other channels (notshown) through which, e.g., irrigation or suction may be provided to asurgical site, in addition to channels associated with active controlmechanisms (e.g., cables for steering or locking).

End effectors 508A, 508B may each be coupled to the distal ends ofinstruments 502A, 502B respectively. The surgical instruments 502A, 502Brepresent at least two of the robotic surgical tools 101. The endeffectors 508A-508B may or may not be gripping tools to help assist insteering or guiding the entry guide to a surgical site. The endeffectors 508A-508B may be sharp surgical tools, such as scissors forexample. The surgical instruments 502A-502B may be coupled to the lumenwalls in the lumens 506A-506B by the retention, locking, or attachmentmeans such that the instrument tips of the end effectors are safelyinside the entry guide and cannot harm tissue when the entry guide isbeing steered to the surgical site by pushing and/or pulling on theinstruments 502A-502B.

Instrument assembly 500's cross section may be circular, elliptical, orother shape (e.g., rounded rectangle or other polygon). Variouscombinations of surgical instruments 502A, 502B and entry guide 504 maybe rigid, passively flexible, and actively flexible, as well aslockable, and each instrument or entry guide may be composed along itslength of multiple different constructions.

The entry guide 504 may include an optional imaging system 511 (e.g.,one or more image capture chips with associated optics and electronics)positioned at its distal end. The imaging system 511 has a field of viewthat may be used to assist advancing guide tube 504 and that allows asurgeon to view end effectors 508A, 508B working at a surgical site.Imaging system 511 may be coupled to an articulable structure attachedto the entry guide 504 to provide independent motion of the imagingsystem in one or more degrees of freedom. Alternately, the imagingsystem may itself be coupled to the end of an instrument assembly whichmay be inserted through one of the lumens in the entry guide to provideimaging at the distal end. Such an imaging instrument assembly may alsobe used to provide a steering or locking function.

The instrument assembly 500 may be inserted into a patient via acannula, a natural orifice, or an incision. In some instances, acannula-type guide may be used to assist insertion via natural orifice.Cannula-type guides may be straight or curved to facilitate insertion(e.g., for entry into the esophagus via the mouth and throat).

Instrument assembly 500 may be initially inserted in a rigidized orlocked state. The instrument assembly 500 may be flexible in an unlockedstate and actively steered during insertion in order to reach a targetsurgical site.

In some embodiments, the instruments 502A, 502B may each be lockedaxially into the tip of the entry guide 504, or at another chosenlocation along the length of the lumens of the entry guide 504. The tipof the entry guide may then be steered by pushing on the proximal end ofone instrument while simultaneously pulling on the proximal end of theother instrument.

FIGS. 5D and 5E are diagrammatic perspective views that illustrateaspects of a removable instrument 548 that is held in place within alumen 540 of the entry guide 504. The distal end 542 of the entry guide540 has an opening 544 through which the distal end of the instrumentpasses. The opening 544 is optionally made non-round to prevent theinstrument from rolling within entry guide 540. An optional fitting 546(e.g., a spring that snaps into a detent, etc.) holds the instrument'send effector 548 in position to keep the instrument from translatingthrough the lumen and the entry guide. A round opening 544 allows theinstrument to roll while fitting 546 keeps the instrument fromtranslating. When the fitting 546 releases the instrument (e.g., whensufficient pulling force is applied), the instrument may be withdrawnfrom the entry guide. The roll prevention configuration and the fittingare illustratively shown at the distal end of the entry guide but may beplaced at various positions (e.g., at the insertion end of the entryguide). The roll prevention configuration and the fitting can be used inthe various aspects for other instrument and guide tube combinations.

Alternatively, the instruments 502A, 502B may be left to slide freely inthe entry guide 504, but may be articulated individually or in concertto alter the shape of the entry guide at its proximal end or anywherealong its length. In some aspects, two or more instruments may beinserted each individually in different lumens to different depthswithin the entry guide to provide articulation of the entry guide alonga significant portion of its length.

In some aspects, the instruments 502A, 502B and entry guide 504 may bealternatively coaxially advanced. Both instruments may be advanced andheld in a fixed position while the entry guide is advanced over bothinstruments and locked in the position imposed by the instruments. Byrepetition of this process, the entry guide may be progressed in stepsfrom the point of insertion to the surgical site. In another aspect, afirst instrument is advanced and held or locked, the entry guide isadvanced over the first instrument, and then the second instrument isadvanced and held or locked so the that entry guide can be advanced overit. For example, instrument 502A may be actively steered (only thedistal section of the instrument (or guide tube) need be activelysteerable) part way along the trajectory to the surgical site and thenlocked. The more proximal sections of the instrument may be passive ormay use curve propagation as the instrument (or guide tube) advances.Curve propagation is disclosed in, e.g., Ikuta, K. et al., “Shape memoryalloy servo actuator system with electric resistance feedback andapplication for active endoscope,” 1988 IEEE International Conference onRobotics and Automation, Apr. 24-29, 1988, Vol. 1, pages 427-430, whichis incorporated by reference. The entry guide 504 may then be passivelyadvanced to the distal end of instrument 502A and locked to supportfurther advancement of instruments. The coaxial alternating advancingand locking continues until the surgical site is reached along thedesired trajectory.

Alternatively, the whole body or just the distal section of entry guide504 is actively steerable and lockable, and instruments 502A, 502B arepassively advanced inside the entry guide until the surgical site isreached. If both the surgical instruments 502A, 502B and the entry guide504 are actively steerable, then they may “leapfrog” each other as theycoaxially advance and lock along the trajectory to the surgical site.Such coaxial insertion may also be used with any combination of one ormore instruments and a guide tube.

Referring now to FIGS. 5F-5H, a plurality of robotic surgical tools502A-502B may be used to influence the behavior of an entry guide 504.The shape and behavior of the entry guide 504 may be influenced by theinsertion of at least two instruments inserted into two lumens withtheir distal ends adjacent to the distal end of the entry guide andfixed or locked in place. That is, the distal ends of the instruments(end effectors 508A-508B) are aligned with the distal end of the entryguide 504 and locked there together. With the at least two tools502A-502B opposed (e.g., left lumens and right lumens) to one another inlumens radially spaced apart equally, they can actuate the entry guide.

Steering the entry guide 504 with a plurality of robotic surgical toolsis advantageous because it uses the same actuation mechanism as theinstrument, and minimizes required instrument changes. The entry guide504 can be loaded up with the required robotic surgical instruments ortools, installed and steered to surgical site, and the used toefficiently operate on tissue in the surgical site without instrumentchanges or minimizing the time consuming instrument changes.

In FIGS. 5F-5H, the distal ends or other part of the tools 502A-502B maybe locked within lumens of the entry guide 504 by a retention, locking,or attachment device, such as described with reference to FIGS. 5D-5E.When locked within the lumens to the entry guide 504, the shafts orinstrument bodies of the instruments may be used liked cables. In oneaspect of the invention, the pair of tools 502A-502B may have theirshafts alternatively pushed and pulled or conjunctively pushed or pulledto shape the entry guide as illustrated by the arrowheads 517A-517F.

During surgery, the locking device may rotationally lock an instrumentto the entry guide within a lumens to prevent tensional wind-up of along flexible instrument shaft in response to a torque on the instrumenttips. If the shaft of the tool is not locked within the lumens duringsurgery, the instrument may roll near the distal end of the entry guidewhen attempting to manipulate tissue by movement of the instrument tipsin an X or Y direction. Without locking a shaft of the tool to the entryguide within the lumens, the tip may remain stationary while the shafttwists inside lumen of the entry guide.

In FIG. 5F, the tools 502A-502B are pushed with the same force togetheras illustrated by arrowheads 517A-517B to steer the distal end of theentry guide straight further into a body cavity.

In FIG. 5G, to steer the entry guide to the right, tool 502A may bepushed along its insertion axis as indicated by arrow 517C and tool 502Bmay be pulled along its insertion axis as indicated by arrow 517D.

In FIG. 5H, to steer the entry guide to the left, tool 502A may bepulled along its insertion axis as indicated by arrow 517E and tool 502Bmay be pushed along its insertion axis as indicated by arrow 517F.

In another aspect of the invention, the tools 502A-502B may beindividually shaped with their own control cables to impart a similarshape to the entry guide 504. As shown in FIG. 5I, each tool 502A-502Bmay have a steerable tip portion 522A-522B coupled to a passive bodyportion 523A-523B that may be locked to hold its shape. Moreover, thetools 502A-502B may be used in series and independently steered or bentto actuate the entry guide 504 without being locked thereto.

In FIG. 5I, the cables 515A-515B and 516A-516B respectively control theorientation of the steerable tip portions 522A-522B of the shafts of thetools 502A-502B. With the cables held in a steady state with the toolshafts being steered straight, the distal end of the entry guide 504 maybe steered straight as it is inserted into a body cavity. Additionally,the tools 502A-502B may be staggered in series along a path to asurgical site with the entry guide 504 being pushed over their shapes.The tools 502A-502B may slide within the respective lumens 506A-506B andleap-frog in front of each other in series towards the surgical sitewith the entry guide 504 being pushed over each. For example, tool 502Bmay have its passive body portion 523B rigidly locked and its steerabletip portion held in steady state by its cables 516A-516B so that thetool 502A and the entry guide 504 may advance forward and take on theshape of tool 502B.

In FIG. 5J, some cables 515D, 516C are paid out while other cables 515C,516D are pulled in to steer the steerable tip portions 522A-522B of theshafts of the respective tools 502A-502B in opposite directions to steerthe entry guide 504 through a pair to turns forming an S shape.

In FIG. 5K, some cables 515E, 516E are pulled in while other cables515F, 516F are paid out to steer the steerable tip portions 522A-522B ofthe shafts of the respective tools 502A-502B in the same direction sothat the entry guide 504 may follow along in the same direction.

While FIGS. 5I-5K illustrate an independent serial progression of tools502A-502B within the lumens to shape the entry guide, the tools mayalternatively be extended and in front of the entry guide and operatedin parallel together out of the lumens to steer and shape it towards asurgical site.

FIGS. 5I-5K illustrate robotic surgical tools 502A-502B beingprogressively used to steer and shape an entry guide. FIGS. 5D-5Eillustrate a retention, locking or attachment mechanism to couple aportion of a tool to a lumen wall of the entry guide. However,specialized steering instruments may be used instead to progressivelylock and steer the entry guide to influence its shape. Similar to tools508A-508B illustrated in FIGS. 5F-5H, the specialized steering tools maylock in attachment to the lumen wall near the distal portion of theentry guide and steer it by pushing and/or pulling on the shafts of thespecialized steering instruments. The steering instruments are removedfrom the lumens and replaced with surgical instruments after the entryguide has reached the surgical site. Similar to tool 508B illustrated inFIGS. 5I-5K, the specialized steering instruments need not be insertedfully into the lumens of the entry guide to steer and controlintermediate portions of the entry guide. The steering instruments maybe locked to the lumen wall at intermediate positions between theproximal and distal ends of the entry guide. The lumen walls of theentry guide may have internal ridges along its length so that thesteering instruments (or surgical instruments) can attach to the lumenwall at particular depths when inserted.

The shaft of these steering instruments may have a smaller diameter thana surgical instrument but for a lumen locking mechanism. The shaft ofthese steering instruments may be as simple as a cable with a collar orexpandable pins at a distal end to lock to the lumen wall at variouspositions along its length. As the shaft of the steering instruments maybe smaller in diameter, a plurality of steering/shaping instruments maybe inserted into the same lumen of an entry guide. Each of the pluralityof steering instruments in the same lumen may be inserted to differentdepths and attach to different sections of the entry guide. In thismanner, the entry guide has a complex but removable cable control systemalong its length that can steer more than one portion of the entryguide.

With more than one steering instrument is a single lumen, the instrumentcross section is much smaller than the lumen and may not supportcompression without buckling. Thus, the shafts of the steeringinstruments in this case are under tension. In order to steer the entryguide, instruments at same depth are placed in other lumens. Theretention, locking, or attachment mechanism is designed to avoid fillingthe entire cross-section of the lumen so that more distal instrumentscan pass by it in the same lumen. The retention, locking, or attachmentmay consist of a pair of opposing extendable pins to engage the internalridges in the lumen wall of a lumen.

Referring now to FIGS. 9A-9F, an entry guide system 900 is illustratedincluding a plurality of robotic surgical tools 902A-902B and an entryguide 504. The plurality of robotic surgical tools 902A-902B areoperated in parallel together to steer and shape the entry guide 504towards a surgical site. Steerable tip portions 522A-522B of therespective robotic surgical tools 902A-902B are flexible (see shaft 106of tool 101 illustrated in FIG. 3A), extend out of the lumens 506A-506Bin front of the entry guide 504, and may be steered in unison. Tofurther steer and shape the entry guide 504, the proximal ends of thetools 902A-902B may also be alternatively or conjunctively pushed andpulled so as to maximize the forces applied to the distal end of theentry guide 504. The proximal ends of the steerable tip portions522A-522B are locked or attached to the lumen walls near the distal endof the entry guide 504.

The plurality of robotic surgical tools 902A-902B may each include anend effector 932A-932B. The end effectors 932A-932B may or may not begripping tools to help assist in steering or guiding the entry guide toa surgical site. Instead, the end effectors 932A-932B may be sharp toolsfor surgical procedures, such as scissors for example. One or more softnosecones may be provided, such as on a camera tool, so that the sharpinstrument ends of the end effectors 932A-932B can tuck into the one ormore nosecones and avoid injuring tissue as the steerable tip portions522A-522B are steered in front of the distal end of the entry guide.With the plurality of instruments 902A-902B being steerable devices forthe entry guide, the entry guide system 900 is analogous to an endoscopewith a steerable tip and a pushable body, However, the entry guide maybe made rigid (lockable) by various locking devices.

The entry guide 504 may be a passive entry guide with minimal or nomeans to steer or influence its shape. However, the entry guide 504 maybe lockable with locking cables or other locking means described herein.Because the entry guide 504 may be a passive entry guide without its ownmeans to steer, a substantial portion of the cross section of theflexible entry guide may be made available for instrument lumens,allowing for a substantial increase in performance of the tools902A-902B with respect to an active entry guide with its own steeringcapability.

The robotic surgical tools 902A-902B may respectively include sensors930A-930B adapted to allow the robotic control system to determine therespective three dimensional tool shape in space. Various known shapesensing systems may be used. As one non-limiting example, informationfrom encoders coupled to actuating motors that steer the tool (e.g.,with steering cables that extend to various positions on the flexibletool) may be used to determine the tool shape in three dimensionalspace. As another non-limiting example, three dimensional tool shapeinformation may be obtained from one or more fiber optic shape sensorsextending the length of the instrument or tool (one such fiber opticshape sensing system is available from Luna Innovations Corporation,Roanoke, Va.). Fiber optic shape sensors are further described in U.S.patent application Ser. No. 11/491,384, entitled ROBOTIC SURGERY SYSTEMINCLUDING POSITION SENSORS USING FIBER BRAGG GRATINGS, filed on Jul. 20,2006 by inventors David Q. Larkin, et al (U.S. Pat. App. Publ. No. US2007/0156019 A1), which is incorporated herein by reference. Variousother shape sensing systems include sensors (e.g., to sense spacebetween links in the tool, to sense triangulation information fromexternal transmitters, etc.) placed along the tool. Shape informationmay be used to control the tool's shape.

A computer, such as computer 151 in the surgeon's console 150illustrated in FIG. 1C, may include a tool control and tracking softwaresystem 184 responsive to the sensors 930A-930B. The tool control system184 is capable of controlling the steerable tip portions 522A-522B sothat each has substantially the same shape as the others as they arearticulated towards a surgical site.

In FIG. 9B, the entry guide system 900 is inserted through an opening950 into a body 950 and extended towards a surgical site 999. Therobotic surgical tools or instruments 902A-902B with their respectivesteerable tip portions 522A-522B of their shafts are steeredsubstantially as a group to follow a path 952 between tissue 954-955 tothe surgical site 999. As the robotic surgical tools 902A-902B are notlocked into the entry guide 504, they may extend further in length outof the lumens, beyond a surgical working length that may be used duringsurgery. The entry guide 504 follows along in the path 952 behind therobotic surgical tool tip portions 522A-522B.

In FIG. 9C, the entry guide system 900 may generally be pushed andguided further along the path 952 under remote control of the surgeon'sconsole. The steerable tip portions 522A-522B of the robotic surgicaltools 902A-902B may be steered and shaped by actuators under remoteinstrument control of the surgeon's console. The entry guide 504 may bepushed and steered along the path 952 by actuators under remote entryguide control of the surgeon's console. The entry guide 504 is flexiblebut sufficiently stiff to receive a pushing force outside of thepatient's body 950 so that it may follow the shape of the path 952 madeby the robotic surgical tool tip portions 522A-522B.

In FIG. 9D, the entry guide system 900 is further inserted into the bodyalong the curved path 952 with the robotic surgical tools 902A-902Breaching towards the surgical site 999.

In FIG. 9E, the distal ends of the robotic surgical tools 902A-902B ofthe entry guide system 900 have reached the surgical site together.However, the entry guide system 900 may be further inserted into thebody along the curved path 952 prior to performing surgery.

In FIG. 9F, the entry guide system 900 may be further inserted into thebody along the curved path 952. The entry guide 504 may be advanced overthe robotic surgical tools 902A-902B to provide support for them closerto the surgical site 999. The entry guide 504 or portions thereof nearthe surgical site 999 may then be locked substantially in place toresist movement so as to support the robotic surgical tools 902A-902Bduring surgery. Upon reaching the surgical site 999, the roboticsurgical tools 902A-902B may be deployed, spreading out away from theirpositions used during insertion to guide the entry guide 504 down thepath 952. The deployment of the robotic surgical tools 902A-902Bprovides a working separation to perform a surgical procedure at thesurgical site 999.

Described previously with reference to FIGS. 9A-9F, a plurality ofrobotic surgical tools 502A-502B extending out from the lumens of anentry guide 504 were operated in parallel together to guide it along apath to a surgical site. Alternatively, a plurality of robotic surgicaltools extending from the lumens may be operated in a serial fashion withalternating advancement to guide a locking entry guide along a path to asurgical site.

Referring now to FIGS. 7A-7C, a schematic diagram of an entry guidesystem is illustrated including an entry guide 108 and a plurality ofrobotically controlled steering tools 700A-700C. The shafts 701A-701C ofthe respective plurality of robotically controlled steering tools700A-700C may be used to shape and influence the behavior of the entryguide 108 as it is inserted into the patient P's body. The shafts701A-701C of the respective plurality of robotically controlled steeringtools 700A-700C are significantly longer than the length of the entryguide 108 so that they may extend out beyond the distal end of the entryguide. The entry guide 108 may slide over the shafts 701A-701C of therespective plurality of robotically controlled steering tools 700A-700Cand follow their shape along a path to a surgical site. The distal endof one or more shafts 701A-701C may respectively include a camera704A-704C to capture images to steer the steerable end portions of theshaft within the body towards a surgical site.

In FIG. 7A, prior to initial insertion of the entry guide 108 into thebody, the steering tools 700A-700C with their extended shafts may befirst inserted first. With the lumens 405A-405C over the shafts701A-701C respectively, the entry guide 108 may then be slid over theshafts towards the surgical site to follow their shapes for guidance tothe surgical site. The first steering tool 700A has its shaft 701Ainitially extended out farthest away from the distal end of the entryguide 108.

In FIG. 7B, the entry guide 108 has been inserted into the body over theshafts 701A-701C. The steering tool 700C is made flexible and can besteered out further from the distal end of the entry guide 108 towardsthe surgical site. The steering tool 700C may be advanced further alongthe path than the other tools 700A-700B in a serial fashion. The entryguide 108 may then be inserted further into the body over the shafts701A-701C of the tools 700A-700C towards the surgical site.

In FIG. 7C, the entry guide 108 has been inserted still further into thebody over the shafts 701A-701C with its distal end located near thesurgical site. Note that the distal end of the entry guide 108 mayextend out over the distal ends of one or more of the shafts 701A-701B.

After positioning the distal end of the entry guide 108 with thesteering tools, it may be rigidized to keep its shape so that all thesteering tools 700A-700C may be removed to allow robotic surgical toolsto be inserted into the lumens 405A-405C.

In an alternative embodiment of the invention, a single non-lockingcamera/grasping instrument may be used to navigate an entry guide systemto a surgical site. The single non-locking camera/grasping instrumentcan be steered and capture images to provide vision while it isinserted. The single non-locking camera/grasping tool can grasp tissueto anchor its distal portion. The entry guide may then be slide over thetool following its shape and path to the surgical site. The entry guidemay then be rigidified so that other instruments may be inserted intoother available lumens. The non-locking camera/grasping tool maymaintain its grasp on tissue to hold it anchored during surgery and useits camera to provide images of the surgical site.

Robotically Controlled Steering Tool for Entry Guide Shaping

A single special tool, a robotically controlled steering tool, such asthe tool 101 illustrated in FIGS. 3A-3C but without an end effector 348may be used to influence the shape and behavior of the entry guide 108.Any cables that might have been used to actuate an end effector areinstead used to steer the shaft. The tool 101 includes theflexible/steerable/lockable shaft 106 that is inserted into aninstrument lumen of the entry guide 108. The flexible/steerable/lockableshaft 106 is a cable-articulated snake mechanism controlled by one ormore actuators. The flexible/steerable/lockable shaft 106 may be formedwith the vertebrae 372-376 shown in FIG. 3C.

Greater actuating (steering) forces may be applied by a roboticallycontrolled steering tool to shape and influence the behavior of theentry guide, or alternatively reduce the cross-sectional dimensions ofthe entry guide by eliminating some or all of the steering controlcables of the entry guide 108 while providing similar actuating(steering) forces.

Pre-Curved Stiffening Rods for Entry Guide Shaping

Another means of influencing the behavior and shape of the entry guide108 is by insertion of a preformed device into one or more of theinstrument lumens of the entry guide. Such a device may be a pre-curvedstiffening rod or tube that is inserted into the instrument lumens toshape and influence the behavior (e.g., increase stiffness or altershape) in all or portions of the entry guide. Such a pre-curvedstiffening rod or tube may additionally have a varying cross-sectionalong its length to alter its bending stiffness as needed to provide thedesired bend profile. Moreover, the end position of a stiffening rod maybe moveable to change its behavior during insertion. For example, ashort stiff tip with a small bend radius and limited total bend anglemay be used to navigate down a lumen. Altering the end position, alonger, more flexible tip with a large total bend angle may be formed inthe stiffening rod for traversing open space.

Referring now to FIGS. 8A-8F, schematic diagrams of an entry guidesystem is illustrated including an entry guide 108 coupled to theplatform 112 and a plurality of pre-curved stiffening rods 800A-800N. Inthis system, the plurality of pre-curved stiffening rods 800A-800N maybe used to shape and influence the behavior (e.g., increase stiffness oralter shape) in all or portions of the entry guide 108. The pre-curvedstiffening rods 800A-800N have a stiffness that is tailored so that itsstiffness level is low enough to allow it to be forced to take the shapeof the entry guide when inserted, but high enough so that a significantportion of the force available in the entry guide actuation means isneeded to overcome the shape of the pre-curved stiffening rod. Thedifference between these two forces is the amount of force available tobias the shape of the entry guide in the direction of the insertedstiffening rod. Alternatively, an actuation force to overcome thestiffness of the stiffening rods may be derived from an external supportsuch as an overtube to keep the entry guide 108 in its desired position.

The stiffening rods 800A-800N include a curved portion 801A-801N,respectively, that may differ from each. The curved portion 801A-801N ofthe stiffening rods 800A-800N may be non-circular so that they do nottwist inside the lumens 405A, 405B′, 405C (generally referred to aslumens 405) of the entry guide 108. The stiffening rods 800A-800N mayallow for the application of additional actuation force in apre-determined direction to the section of the entry guide 108 that isoccupied by the curved portion 801A-801N of the stiffening rods.

The length of the stiffening rods 800A-800N may be longer than thelength of the entry guide 108 so that they can extend out from theproximal end of the entry guide and can be inserted to a chosen depthrelative to specific anatomic features. With a stiffening rod 800A-800Ninserted into a lumen, the entry guide may be further inserted using thecurved portion 801A-801N of the stiffening rod as a guide. Thestiffening rods 800A-800N may be interchanged to obtain different bendangles to help bend the entry guide, such as through the throat of apatient during trans-oral insertion, or traversing the peritoneum duringprocedures requiring significant retroflex ion of the entry guide, suchas trans-gastric cholecystectomy.

To determine where to position stiffening rods, the entry guide 108 mayhave a camera 820 at its distal end to view how it should be steeredwith the stiffening rods as it is inserted into the body cavity.

In FIG. 8A, the stiffening rods 800A-800N have yet to be inserted into alumen 405A-405C of the entry guide 108 to assist in steering and/orshaping it. Alternatively, a stiffening rod 800A-800N may be insertedinto each of the lumens 405A, 405B′, 405C prior to the initial insertionof the entry guide 108 into a patient. The initial insertion of theentry guide 108 was straight ahead between obstructions 810A-810B withlittle bending. The proximal end of the entry guide 108 may be loweredby the platform 112 so as to insert the distal end of the entry guideinto the patient's body P.

In FIG. 8B, a first pre-curved stiffening rod 800A is inserted into afirst instrument lumen 405A to assist in steering and/or shaping theentry guide 108 between the obstructions 810A and 810C of the bodycavity. The curved portion 801A of the stiffening rod 800A initiallyconforms to the shape of the entry guide 108.

In FIG. 8C, a second pre-curved stiffening rod 800B is inserted into asecond instrument lumen 405C to assist in steering and/or shaping theentry guide 108 between the obstructions 810A and 810C of the bodycavity. With the added actuation force of the second stiffening rod800B, the curved portions 801A-801B of the stiffening rods 800A-800B mayturn a portion of the entry guide 108 to steer the distal end betweenthe obstructions 810A-801B. The entry guide 108 may be further insertedinto the body cavity.

In FIG. 8D, the entry guide 108 is further inserted into the body cavitybetween obstructions 810A and 810C such that the distal end of the entryguide is located in the surgical site. The curved portions 801A-801B ofthe stiffening rods 800A-800B continue to turn the distal end of theentry guide around obstruction 810A.

In FIG. 8D, a locking device 850 is inserted into the lumen 405B′ torigidize the entry guide 108 so that the stiffening rods 800A-800B maybe removed and tools inserted. Alternatively, the entry guide 108 mayhave an integrated locking device to rigidize itself to hold its shapeand position during surgery without requiring an instrument lumen to beused for this purpose.

In FIG. 8E with the entry guide 108 being rigid in a locked mode fromthe locking device 850, the first pre-curved stiffening rod 800A may beremoved from the first instrument lumen 405A. This vacates the lumen405A so that a robotic surgical tool may be inserted.

In FIG. 8F with the entry guide 108 being rigid in a locked mode fromthe locking device 850, the second pre-curved stiffening rod 800B hasbeen removed from the second instrument lumen 405C. With both instrumentlumens 405A, 405C vacant, robotic surgical tools 101A, 101B may berespectively inserted into these lumens and the entry guide 108 so thata robotic surgical procedure may be performed near the distal end of theentry guide 108.

Upon completion of the surgical procedure, the robotic surgical tools101A,101B are removed from the lumens of the entry guide 108. Thelocking device 850 is unlocked so as to make the entry guide flexibleand may be removed from the lumen 405B′. The entry guide 108 may then bepulled at the proximal end by the platform 112 so as to remove it fromthe patient's body.

Entry Guide With Integrated Instrument Head

As described herein, a lumen may be closed at one end, such as lumen405B′ described with reference to FIGS. 8A-8E. In this case, a fixedinstrument may be included in the distal end of the entry guide 108 inalignment with longitudinal axis of the lumen. For example, the fixedinstrument may be a camera at the distal end of the entry guide, such asthe camera 820 described with reference to FIGS. 8A-8E. This leaves theproximal portion of the lumen behind the head substantially empty andavailable to use with an actuating means.

Referring to FIG. 10, a cross section of a distal end 402 of the entryguide 108 is illustrated. The distal end 402 of entry guide includes acamera 1002 mounted in the closed lumen 405B′ with the closed end 1005.The camera 1002 is substantially aligned with the cross section of theclosed lumen 405B′.

The camera 1002 may be hermetically sealed to avoid body fluids fromseeping therein so that it can be readily sterilized and reused. One ormore electrical cables 1066A-1066B may couple to the camera 1002 so thatpower can be coupled to an image sensor 1051 and digital data of thecaptured images may be transferred from the image sensor to the videodisplays of the surgical system. One of the one or more electronicinterface connectors (not shown) at the proximal end of the entry guide108 may couple to the electrical cables 1066A-1066B.

The camera 1002 includes an image sensor 1051 (e.g., charge coupleddevice array), one or more lenses 1052A-1052B, and a transparent cover1061 aligned together along an optical axis 1060 by a housing 1062. Theimage sensor 1051 captures images from light passing through thetransparent cover. The one or more lenses 1052A-1052B may collimate thelight parallel to the optical axis and then focus it into the imagesensor 1051. The transparent cover 1061 may be hermetically sealed tothe camera housing 1062 and/or the distal end of the entry guide 108.The camera 1002 may further include a filter 1054 aligned to the opticalaxis 1060 by the housing 1062 before the light rays reach the imagesensor 1051. The camera may be adapted to provide stereo vision byproviding multiple imaging sensors, lens arrays, etc, or by other knownstereo imaging means.

The camera 1002 or other instrument at the end of the lumen 405B′ allowsanother device (e.g., stiffening, locking, or steering device) to beinserted into the lumen 405B′ behind the camera up to the closed end1005 to shape and influence the behavior of the entry guide and thusmitigates the loss of instrument function that might result bydedicating the full length of the lumen to the camera function.

While a camera 1002 has been shown and described, other tools may beintegrated into the distal end 402 of the entry guide 108 substantiallyaligned with the cross section of the closed lumen 405B′ to provideanother tool to efficiently use an entry guide system.

Locking Devices to Rigidize the Entry Guide

The stiffening rods described previously with reference to FIGS. 8A-9Dmay hold the shape of the flexible entry guide on their own if leftinserted within the lumen. However, they may need to be removed to allowinsertion of a robotic surgical tool. Moreover, flexible devices ortools inserted into the instrument lumens may require a differentmechanism to lock the entry guide into a rigid state so that itsposition and shape to the surgical site is substantially held.

A simple means of influencing the entry guide behavior by insertion of aflexible locking device into one of the instrument lumens. The flexiblelocking device is initially a flexible device that is inserted into theinstrument lumens. The flexible locking device is sized to fit tightlywithin the instrument lumen. After insertion, the flexible lockingdevice may be rigidized so that the shape of the entry guide may be heldduring surgery, for example.

Aspects of locking devices are shown and described in the following U.S.patents which are all incorporated herein by reference: U.S. Pat. No.3,096,962, entitled LOCKING DEVICE FOR A MEASURING APPARATUS OR THELIKE, issued to P. J. Meijs on Jul. 9, 1963; U.S. Pat. No. 3,546,961,entitled VARIABLE FLEXIBILITY TETHER, issued to T. Marton on Dec. 15,1970; U.S. Pat. No. 4,949,927, entitled ARTICULABLE COLUMN issued toMadocks et al. on Aug. 21, 1990; U.S. Pat. No. 5,251,611, entitledMETHOD AND APPARATUS FOR CONDUCTING EXPLORATORY PROCEDURES, issued toZehel et al. on Oct. 12, 1993; U.S. Pat. No. 5,759,151, entitledFLEXIBLE STEERABLE DEVICE FOR CONDUCTING EXPLORATORY PROCEDURES, issuedto Robert H. Sturges on Jun. 2, 1998; and U.S. Pat. No. 5,899,425,entitled ADJUSTABLE SUPPORTING BRACKET HAVING PLURAL BALL AND SOCKETJOINTS, issued to Corey Jr. et al. on May 4, 1999.

Generally, when cylinders and spheres of a flexible locking tool, areloosely constrained by the locking cables such that the frictionalforces between them are small. In this case the respective flexiblelockable shaft flexes easily. When a cable or rod is tensioned at anactuating base the end cylinder is pulled with a force towards a firstcylinder such that the cylinders and spheres are compressed togetherthereby increasing the friction between the contacting surfaces andeffectively locking the shaft into a rigid shape.

Upon releasing the tension in the locking cables, mating surfaces maynaturally separate if a sufficient force is present to sufficientlystretch the cable. Otherwise, springs may be added to the flexiblelocking tools to separate the mating surfaces to reduce the friction andallow the shafts to flex. Alternatively, an unlocking tool or stiffeningrod may be inserted into an adjacent lumen to stretch the entry guideand the shaft of the locking tool.

While the shape of the entry guide may be held rigid by an instrumentinserted into a lumen, a locking device may be incorporated to be anintegral part of the entry guide. For example, a locking device may beinserted in a center lumen and formed as an integral part of the entryguide. Alternatively, the locking device may be incorporated as part ofa flexible sleeve around the entry guide.

Referring now to FIGS. 6A-6C, a cutaway view of an entry guide system1300 is illustrated. The entry guide system 1300 includes the flexibleentry guide 108 surrounded by a flexible lockable sleeve 1301. The entryguide 108 is coaxial to the flexible lockable sleeve 1301 and isinserted and steered with the sleeve into a patient's body. A proximalend of the entry guide 108 and sleeve 1301 are coupled to the platform112. The distal end of the sleeve 1301 extends down to be near thedistal end of the entry guide 108.

The flexible lockable sleeve 1301 is formed of a plurality of lockablerings 1310. A plurality of locking cables 1320 are routed throughchannels 1312 in each of the locking rings 1310. A curved convex surface1324 of each lockable ring 1310 may slide against a curved concavesurface 1326 in a neighboring lockable ring.

A plurality of actuators 1350A-1350C may be coupled to the lockingcables 1320 to robotically control the entry guide system 1300 and theflexible lockable sleeve 1301. Upon substantial equal tensioning in thecables 1320, the flexible lockable sleeve 1301 may be locked into arigid position so that the coaxial entry guide 108 is constrained in itsshape in a rigid position. In this locked position, robotic surgicaltools 101 may be inserted into the plurality of lumens 405 in the entryguide to perform a robotic surgery near the distal end of the entryguide system 1300.

Releasing the Entry Guide Shape

Upon completion of the minimally invasive surgical procedure, therobotic surgical instruments and the entry guide may be removed. Howeverif the tools and/or the entry guide are locked in shape, they should bereleased from their rigid shapes (rigid mode) to become a flexible shape(flexible mode) prior to the withdrawal of the entry guide.

For those devices with a cable locking mechanism, the cable tension isinitially released so that the rigid shaped form of the tool/entry guidemay become released. The release of the cable and the force on theplatform to remove the entry guide may be sufficient to release theentry guide from its rigid shape. However, various devices may be usedto assist in releasing the friction between joints in a flexibletool/entry guide.

For example, the tool/entry guide may have springs between joints orvertebrae which may expand and release the friction. A non-compressibleshaft may be inserted into a closed base lumen of the entry guide. Thenon-compressible shaft presses outward on the last joint of flexibleshaft while the platform pulls outward on the entry guide to assist inreleasing the friction between joints.

Transluminal Surgery

Transluminal surgery with a flexible entry guide system may use acombination of the apparatus and methods described herein. The entryguide may first be steered through intermediate tissue or through anatural body lumen (e.g., down esophagus to stomach). The entry guidemay generally be steered with one or more instruments having a flexiblesteerable shaft, such as tools 502A-502B described with reference toFIGS. 5A-5C. Alternatively, the entry guide may be steered with one ormore instruments with shafts having a portion locked to the entry guidewithin the lumens, such as tools 502A-502B described with reference toFIGS. 5F-5H. The instruments within the lumens may be extended outbeyond the entry guide to operate on a patient lumen (e.g., stomach) tocreate an opening in which to install a port management device to a wall(e.g., stomach wall). The port management device may be an entry guideovertube that allows for management of insufflation of the stomach orother body cavity. The entry guide may be inserted through the portmanagement device and steered towards a surgical site.

Upon reaching the surgical site, the entry guide may be rigidized. Theentry guide may be rigidized by its own locking tool or an insertablelocking tool. The instruments within the entry guide may be extendedoutward from the entry guide and spread to operate on tissue at thesurgical site. With the entry guide inserted to the surgical site, itsposition may be adjusted by various steering devices, including aninstrument with a portion of its shaft coupled to a lumen wall of theentry guide. The entry guide may then be steered to the portion of thebody cavity (e.g., abdomen) of interest and the instrument unlocked fromthe lumen wall so that it may be used to operate on the tissue.

Conclusion

The embodiments of the invention have now been described with somedetail. The embodiments of the invention may shape and steer an entryguide at points where the entry guide may be only passively flexible.The embodiments of the invention may actuate an entry guide with greaterforce, or avoid applying greater instrument forces to reach a distantsurgical cite without increasing its diameter. Conversely, theembodiments of the invention may reduce the diameter of the entry guideby reducing or eliminating its control cables without reducing the forcethat can be applied thereto. Less cross-section of the entry guide maybe devoted to a dedicated entry guide actuation mechanism with theembodiments of the invention to minimize the diameter of the entryguide. Cross section of the entry guide devoted to delivering andactuated instruments (the instrument lumens) previously used to actuatethe entry guide may be reused to steer, guide, and influence the shapeof the entry guide. The embodiments of the invention may simplify theactuation of the entry guide actuation without reducing itsfunctionality. Moreover, the embodiments of the invention allow theentry guide to assume shapes that may allow traversal of body lumens orcavities that otherwise may not have been possible with the entry guidealone, or by an endoscope alone.

While certain exemplary embodiments have been described and shown in theaccompanying drawings, it is to be understood that such embodiments aremerely illustrative of and not restrictive on the broad invention, andthat the embodiments of the invention not be limited to the specificconstructions and arrangements shown and described, since various othermodifications may become apparent after reading this disclosure. Forexample, some embodiments of the invention have been described withreference to a single instrument or device being used in a single lumenof the entry guide. However a plurality of the locking devices and guidedevices described previously may be used in multiple lumens of the entryguide. Each of the plurality may be positioned to influence the shape ofa different portion of the length of the entry guide. Instead, theembodiments of the invention should be construed according to the claimsthat follow below.

1-20. (canceled)
 21. An apparatus for medical procedures, the apparatuscomprising: a flexible entry guide tube comprising: an instrument lumenextending along a length of the flexible entry guide tube from aproximal end of the flexible entry guide tube to substantially at ornear a distal end of the flexible entry guide tube; and at least onerigidizing cable being actuatable to rigidize a shape of the flexibleentry guide tube in place within a body cavity, wherein the at least onerigidizing cable is further actuatable to steer the flexible entry guidetube as the flexible entry guide tube is guided toward a medical site;and a flexible tool insertable into the instrument lumen, the flexibletool comprising: a steerable portion; and a steering cable extendingwithin the flexible tool to enable independent steering of the steerableportion, wherein articulation of the steerable portion causescorresponding articulation of a distal portion of the flexible entryguide tube, and wherein articulation of the distal portion of theflexible entry guide tube causes corresponding articulation of thesteerable portion of the flexible tool, and wherein the flexible tool isconfigured to extend distally away from the distal end of the flexibleentry guide tube to perform the medical procedure while the shape of theflexible entry guide tube is rigidized by the at least one rigidizingcable.
 22. The apparatus of claim 21, wherein in a first drive mode, theflexible entry guide tube and the flexible tool are configured to beco-articulated.
 23. The apparatus of claim 22, wherein in a second drivemode, the flexible entry guide tube is configured to be articulatedwhile the flexible tool remains passive.
 24. The apparatus of claim 21,wherein the flexible tool comprises an imaging device.
 25. The apparatusof claim 24, wherein the imaging device is configured to capture imagedata as the flexible entry guide tube is guided toward the medical site.26. The apparatus of claim 21, further comprising a manipulator coupledto the flexible entry guide tube, the manipulator configured to controlmovement of the flexible entry guide tube.
 27. The apparatus of claim26, wherein the manipulator is further configured to control movement ofthe flexible tool.
 28. The apparatus of claim 21, further comprising afirst input device and a second input device, wherein the flexible entryguide tube is configured to be steered via signals received from thefirst input device, and wherein the flexible tool is configured to besteered via signals received from the second input device.
 29. A roboticmedical system, comprising: a flexible entry guide tube comprising atleast one rigidizing cable being actuatable to rigidize a shape of theflexible entry guide tube in place within a body cavity, the at leastone rigidizing cable being further actuatable to steer the flexibleentry guide tube as the flexible entry guide tube is guided toward amedical site; a flexible tool insertable into an instrument lumen of theflexible entry guide tube, the flexible tool configured to perform amedical procedure while the shape of the flexible entry guide tube isrigidized by the at least one rigidizing cable; a control system; aprocessor; and a memory comprising machine readable instructions that,when executed by the processor, cause the control system to: receive,via a user input device, a command to drive the flexible tool or theflexible entry guide tube; and control co-articulation of the flexibleentry guide tube and the flexible tool while the robotic medical systemis in a first drive mode, wherein articulation of a steerable portion ofthe flexible tool causes corresponding articulation of a distal portionof the flexible entry guide tube, and wherein articulation of the distalportion of the flexible entry guide tube causes correspondingarticulation of the steerable portion of the flexible tool.
 30. Therobotic medical system of claim 29, wherein the machine readableinstructions further cause the control system to control movement of theflexible tool to extend a distal end of the flexible tool beyond adistal end of the flexible entry guide tube while the robotic medicalsystem is in a second drive mode.
 31. The robotic medical system ofclaim 29, wherein the machine readable instructions further cause thecontrol system to, while the robotic medical system is in a second drivemode, control articulation of the flexible entry guide tube while theflexible tool remains passive.
 32. The robotic medical system of claim31, wherein the machine readable instructions further cause the controlsystem to control movement of the flexible entry guide tube to extend adistal end of the flexible entry guide tube beyond a distal end of theflexible tool while the robotic medical system is in the second drivemode.
 33. The robotic medical system of claim 31, wherein in the seconddrive mode, the flexible entry guide tube is configured to be advancedor retracted while the flexible tool remains stationary.
 34. The roboticmedical system of claim 29, wherein in the first drive mode, theflexible entry guide tube and the flexible tool are each configured toadvance or retract.
 35. The robotic medical system of claim 29, furthercomprising a manipulator configured to control movement of the flexibleentry guide tube and movement of the flexible tool.
 36. The roboticmedical system of claim 35, wherein the machine readable instructionsfurther cause the control system to: receive, via the user input device,an advancement instruction to advance the flexible entry guide tube whenthe robotic medical system is in the first drive mode; and in responseto receiving the advancement instruction, advance the flexible entryguide tube via the manipulator.
 37. The robotic medical system of claim35, wherein the machine readable instructions further cause the controlsystem to: receive, via the user input device, an advancementinstruction to advance the flexible tool when the robotic medical systemis in the first drive mode; and in response to receiving the advancementinstruction, advance the flexible tool via the manipulator.
 38. Therobotic medical system of claim 35, wherein the machine readableinstructions further cause the control system to: receive, via the userinput device, an advancement instruction to advance the flexible toolwhen the robotic medical system is in a second drive mode, wherein inthe second drive mode, the machine readable instructions further causethe control system to control movement of the flexible tool to extend adistal end of the flexible tool beyond a distal end of the flexibleentry guide tube; and in response to receiving the advancementinstruction, advance the flexible tool via the manipulator.
 39. Therobotic medical system of claim 29, wherein the flexible tool comprisesan imaging device, the imaging device configured to capture image dataas the flexible entry guide tube is guided toward the medical site. 40.The robotic medical system of claim 29, wherein the flexible toolcomprises: the steerable portion; and a steering cable extending withinthe flexible tool to enable independent steering of the steerableportion.